The full content of Annals is available to subscribers

Copyright in the material you requested is held by American College Of Physicians
(unless otherwise noted). This email ability is provided as a courtesy, and by using
it you agree that that you are requesting the material solely for personal, non-commercial
use, and that it is subject to ACP's Conditions of Use.
The information provided in order to email this topic will not be used to send unsolicited
email, nor will it be furnished to third parties. Please refer to
American College Of Physicians'sPrivacy
Policy for further information.

Grant Support: By grant R01-DA15612 from the National Institute on Drug Abuse and the Department of Veterans Affairs (Dr. Owens), and grant K01-AI084582 from the National Institute of Allergy and Infectious Diseases (Dr. Bendavid).

Background:A recent randomized, controlled trial showed that daily oral preexposure chemoprophylaxis (PrEP) was effective for HIV prevention in men who have sex with men (MSM). The Centers for Disease Control and Prevention recently provided interim guidance for PrEP in MSM at high risk for HIV. Previous studies did not reach a consistent estimate of its cost-effectiveness.

Objective:To estimate the effectiveness and cost-effectiveness of PrEP in MSM in the United States.

Design:Dynamic model of HIV transmission and progression combined with a detailed economic analysis.

Data Sources:Published literature.

Target Population:MSM aged 13 to 64 years in the United States.

Time Horizon:Lifetime.

Perspective:Societal.

Intervention:PrEP was evaluated in both the general MSM population and in high-risk MSM and was assumed to reduce infection risk by 44% on the basis of clinical trial results.

Results of Base-Case Analysis:Initiating PrEP in 20% of MSM in the United States would reduce new HIV infections by an estimated 13% and result in a gain of 550 166 QALYs over 20 years at a cost of $172 091 per QALY gained. Initiating PrEP in a larger proportion of MSM would prevent more infections but at an increasing cost per QALY gained (up to $216 480 if all MSM receive PrEP). Preexposure chemoprophylaxis in only high-risk MSM can improve cost-effectiveness. For MSM with an average of 5 partners per year, PrEP costs approximately $50 000 per QALY gained. Providing PrEP to all high-risk MSM for 20 years would cost $75 billion more in health care–related costs than the status quo and $600 000 per HIV infection prevented, compared with incremental costs of $95 billion and $2 million per infection prevented for 20% coverage of all MSM.

Results of Sensitivity Analysis:PrEP in the general MSM population would cost less than $100 000 per QALY gained if the daily cost of antiretroviral drugs for PrEP was less than $15 or if PrEP efficacy was greater than 75%.

Limitation:When examining PrEP in high-risk MSM, the investigators did not model a mix of low- and high-risk MSM because of lack of data on mixing patterns.

Conclusion:PrEP in the general MSM population could prevent a substantial number of HIV infections, but it is expensive. Use in high-risk MSM compares favorably with other interventions that are considered cost-effective but could result in annual PrEP expenditures of more than $4 billion.

Primary Funding Source:National Institute on Drug Abuse, Department of Veterans Affairs, and National Institute of Allergy and Infectious Diseases.

Figures

This schematic presents our deterministic dynamic compartmental model. Each box represents a compartment of the population of men who have sex with men, identified by HIV infection status; screening status; PrEP status; and, if infected, HIV disease stage and treatment status. The number within each square denotes the index number of that compartment. The arrows depict population movement from 1 compartment to another and into or out of the population, with the associated variables representing the rates of change. Appendix Table 1 describes the variables. PrEP = preexposure chemoprophylaxis.

Prevalence and incidence of HIV with and without PrEP for HIV prevention.

Under each PrEP scenario, persons initiate PrEP immediately and continue PrEP for the 20-y time horizon or until they reach age 65 y, and PrEP is 44% effective. Top. Prevalence in the overall U.S. MSM population, as simulated by our model, for each scenario for the 20-y time horizon. Bottom. Annual HIV incidence in the susceptible U.S. MSM population, as simulated by our model, for each scenario for the 20-y time horizon. The percentage reduction in HIV incidence relative to the status quo is noted for the first and last years of the model time horizon for each scenario. MSM = men who have sex with men; PrEP = preexposure chemoprophylaxis.

Incremental costs and QALYs are plotted for each PrEP scenario in the general MSM population and in high-risk MSM, with the origin corresponding to the status quo of no PrEP. The lines show the incremental cost-effectiveness ratio relative to the next lower level of PrEP (the preceding scenario with a lower percentage of MSM starting PrEP). Under each PrEP scenario, persons initiate PrEP immediately and continue PrEP for the 20-y time horizon or until they reach age 65 years, and PrEP is 44% effective and costs $10 083 per year, inclusive of monitoring costs. Incremental costs and QALYs are calculated over a 20-y time horizon and are discounted to the present at 3% annually. H-R = high-risk; MSM = men who have sex with men; PrEP = preexposure chemoprophylaxis; QALY = quality-adjusted life-year.

Costs of PrEP for HIV prevention as a function of the percentage of uninfected MSM receiving PrEP.

Total costs of PrEP over 20 y are plotted for each use scenario in the general MSM population (top) and in high-risk MSM (bottom). Total costs of PrEP include the cost of antiretroviral drugs for PrEP, costs of monitoring tests and physician visits, and initiation and discontinuation costs. Under each PrEP scenario, persons initiate PrEP immediately and continue PrEP for the 20-y time horizon or until they reach age 65 y, and PrEP is assumed to be 44% effective and cost $10 083 per year. Costs are calculated over a 20-y time horizon and are discounted to the present at 3% annually. MSM = men who have sex with men; PrEP = preexposure chemoprophylaxis.

Cost-effectiveness of PrEP for HIV prevention as a function of PrEP efficacy and cost.

This 2-way sensitivity analysis shows ranges of the ICER for initiating PrEP in 20% of the general MSM population (top) and in all high-risk MSM (bottom) as a function of PrEP efficacy and cost. Costs depicted on the vertical axes are annual and include all antiretroviral drug and monitoring costs. Incremental costs and QALYs used to calculate the ICERs are calculated over a 20-y time horizon and are discounted to the present at 3% annually. ICER = incremental cost-effectiveness ratio; MSM = men who have sex with men; PrEP = preexposure chemoprophylaxis; QALY = quality-adjusted life-year.

ICER of PrEP for HIV prevention in all high-risk MSM as a function of HIV prevalence.

In the PrEP scenario, all high-risk MSM initiate PrEP immediately and continue PrEP for the 20-y time horizon or until they reach age 65 years. Incremental costs and QALYs used to calculate the ICER are calculated over a 20-y time horizon and are discounted to the present at 3% annually. ICER = incremental cost-effectiveness ratio; MSM = men who have sex with men; PrEP = preexposure chemoprophylaxis; QALY = quality-adjusted life-year.

Tornado diagram of the factors that affect the cost-effectiveness of PrEP for HIV prevention in all high-risk MSM.

The bars show the range of the ICER as each variable is varied by the range listed. The ICER in the base case, $52 443, is shown by the vertical line. In each scenario, all high-risk MSM initiate PrEP immediately and continue PrEP for the 20-y time horizon or until they reach age 65 y. Incremental costs and QALYs used to calculate the ICER are calculated over a 20-y time horizon and are discounted to the present at 3% annually. ICER = incremental cost-effectiveness ratio; MSM = men who have sex with men; PrEP = preexposure chemoprophylaxis; QALY = quality-adjusted life-year.

Comments

Please read the other comments before posting. Contributors must reveal any conflict
of interest.
Comments are moderated and will appear on the site at the discretion of The American
College of Physicians editorial staff. Please be sure your email address is
updated in your account, otherwise the American College of Physicians will not be
able to contact you about your comment.

* = Required Field

Comment Author(s)* (if multiple authors,
separate names by comma)

Example: John Doe

Affiliation & Institution*

Disclosure of Any Conflicts of Interest*
(applies to the past 5 years and foreseeable future) Indicate any potential conflicts
of interest of each author below, including specific financial interests and relationships
and affiliations relevant to the subject matter or materials discussed in the manuscript
(eg, employment/affiliation, grants or funding, consultancies, honoraria, speakers
bureau, stock ownership or options, expert testimony, royalties, donation of medical
equipment, or patents filed, received, or pending). If all authors have none, check
"No potential conflicts or relevant financial interests" in the box below. Please
also indicate any funding received in support of this work. The information will
be posted with your response.

Summary for Patients

Clinical Slide Sets

Terms of Use

The In the Clinic® slide sets are owned and copyrighted by the American College
of Physicians (ACP). All text, graphics, trademarks, and other intellectual property
incorporated into the slide sets remain the sole and exclusive property of the ACP.
The slide sets may be used only by the person who downloads or purchases them and
only for the purpose of presenting them during not-for-profit educational activities.
Users may incorporate the entire slide set or selected individual slides into their
own teaching presentations but may not alter the content of the slides in any way
or remove the ACP copyright notice. Users may make print copies for use as hand-outs
for the audience the user is personally addressing but may not otherwise reproduce
or distribute the slides by any means or media, including but not limited to sending
them as e-mail attachments, posting them on Internet or Intranet sites, publishing
them in meeting proceedings, or making them available for sale or distribution in
any unauthorized form, without the express written permission of the ACP. Unauthorized
use of the In the Clinic slide sets will constitute copyright infringement.